Device for assisting access to a subcutaneous port

ABSTRACT

The device includes a manipulation mechanism for maneuvering a base into position proximate a subcutaneous port. Arms extending from the base enable the device to receive the port and substantially immobilize the port relative to the device. The manipulation mechanism also enables a user to substantially immobilize the device relative to a patient. With the subcutaneous port substantially immobilized by the device, the user has greater confidence and accuracy when inserting a needle into the port. Further, embodiments of the device provide protection to the user to prevent inadvertent sticking of the user as the needle is introduced.

CROSS-REFERENCE TO RELATED APPLICATION(S)

This application is a continuation of U.S. Utility patent applicationSer. No. 15/387,128, filed Dec. 21, 2016, which claims the benefit ofU.S. Provisional Patent Application Ser. No. 62/270,198, filed Dec. 21,2015, which is herein incorporated by reference in its entirety.

BACKGROUND

In the medicine and nursing arts, it is vital that each task beperformed with the highest possible standards of safety and sterility inmind. One challenge faced in these fields is how to protect the users(the doctors, nurse, and the like) of medical equipment and compoundsfrom inadvertently receiving the effects of this equipment whileutilizing them to treat another individual, such as a patient. The tipof a needle does not discriminate and it is not uncommon for medicalpractitioners to inadvertently “stick” themselves when attempting toinject another individual.

This concern is particularly applicable when a patient or otherindividual has had a subcutaneous port installed. Located under theskin, the port has a septum through which drugs can be injected andblood samples can be drawn many times, usually with less discomfort forthe patient than a more typical stick with a needle. A catheter thenconnects the port to a vein.

FIG. 1 shows a standard catheter and port being accessed by a standardinjection device using the method currently approved in the field. Theport is in near constant motion due to its movement under the skin ormovement of the individual in which the port is installed. Thus, thedoctor or nurse's target injection site is in constant motion, leavingthem even more susceptible to the dangers identified above.

To date, there are no assistive devices for accessing ports. What isdesired, therefore, is the development of a device that will allow usersto easily access ports while avoiding accidental needle sticks caused bypatient movements, immobilize a clumsy port catheter that slides aroundunder the skin, and ensure that the user has a clear visual field of theport's center.

SUMMARY

In some embodiments, the present disclosure is directed to a devicecomprising a base, a first arm, a second arm, and at least onemanipulation mechanism for manipulating/maneuvering the device intoposition adjacent or proximate to a port in an individual receiving aninjection.

The device of the present disclosure assists users in easily accessing aport without contaminating the insertion site while keeping the user(such as a nurse or doctor) and patient safe from accidental needlepunctures. The device also allows the user to visualize the insertionsite without having to crowd the area with fingers. The device safelysecures the port while minimizing movement and allowing for correctaccessing to occur the first time.

In some embodiments, the present disclosure is directed to a device forstabilizing a subcutaneous port including a base, a first arm, a secondarm, and at least one manipulation mechanism. In some embodiments, thesecond arm opposes the first arm. In some embodiments, the first arm andthe second arm extend from the base. In some embodiments, at least oneof the base, the first arm, and the second arm are configured tosubstantially immobilize movement of a subcutaneous port with respect tothe device. In some embodiments, the first arm has a first end and thesecond arm has a second end, wherein an opening separates the first endfrom the second end.

In some embodiments, the at least one manipulation mechanism is adjacentthe base, the first arm, and the second arm. In some embodiments, the atleast one manipulation mechanism is apart from the base, the first arm,and the second arm. In some embodiments, the at least one manipulationmechanism extends from at least one of the base, the first arm, and thesecond arm.

In some embodiments, the at least one manipulation mechanism is selectedfrom the group consisting of: a handle, at least one platform, at leastone tube, and combinations thereof. In some embodiments, the at leastone platform is covered. In some embodiments, the at least one platformis oriented vertically. In some embodiments, the at least one platformis curved.

In some embodiments, the at least one of the base, first arm, and secondarm further comprise a stabilizing mechanism. In some embodiments, thestabilizing mechanism is a sidewall. In some embodiments, the sidewallis provided at an angle.

In some embodiments, at least one of the base, the first arm, the secondarm, the at least one manipulation mechanism, and the stabilizingmechanism is adjustable. In some embodiments, at least one of the base,the first arm, the second arm, the at least one manipulation mechanism,and the stabilizing mechanism is flexible.

In some embodiments, the at least one of the base, the first arm, thesecond arm, the at least one manipulation mechanism, and the stabilizingmechanism is configured to interface with a patient's skin and stabilizethe device against the patient's skin. In some embodiments, at least oneof the base, the first arm, the second arm, and the stabilizingmechanism is curved.

In some embodiments, the present disclosure is directed to a method forstabilizing a subcutaneous port including engaging via at least onemanipulation mechanism a device that comprises a base, a first arm, anda second arm opposing the first arm, contacting the base with a patientproximate the subcutaneous port, thus limiting movement of the devicewith respect to the subcutaneous port, stabilizing the device againstthe patient, thus limiting movement of the device with respect to thepatient's skin, and maintaining the device in a stabilized position withthe base proximate the subcutaneous port until a needle is inserted intothe subcutaneous port. In some embodiments, the step of maintaining thedevice in a stabilized position includes maintaining contact via astabilizing mechanism between the subcutaneous port and at least one ofthe base, a first arm extending from the base, and a second armextending from the base.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings show embodiments of the present disclosure for the purposeof illustrating the invention. However, it should be understood that thepresent application is not limited to the precise arrangements andinstrumentalities shown in the drawings, wherein:

FIG. 1 portrays a prior art diagram of a technique for inserting aneedle into a subcutaneous port;

FIG. 2 portrays a device for assisting access to a subcutaneous portconsistent with some embodiments of the present disclosure;

FIG. 3 portrays a further embodiments of the device shown in FIG. 2;

FIG. 4 portrays a further embodiment of the device shown in FIG. 2;

FIG. 5 portrays a further embodiment of the device shown in FIG. 2;

FIG. 6 portrays a further embodiment of the device shown in FIG. 2;

FIG. 7 portrays a method for stabilizing a subcutaneous port utilizingthe device shown in FIG. 2; and

FIG. 8 portrays a further embodiment of the method shown in FIG. 7.

DESCRIPTION

Referring to FIGS. 2, 4, and 5, in some embodiments, the presentdisclosure is directed to a device 1 for assisting a user at aninsertion site 10 for an individual. In some embodiments, device 1comprises a base 100, a first arm 101, and a second arm 102. In someembodiments, second arm 102 opposes first arm 101. In some embodiments,device 1 comprises at least one manipulation mechanism 103. In someembodiments, at least one of base 100, first arm 101, and second arm 102are configured to substantially immobilize movement of a subcutaneousport with respect to device 1.

In some embodiments, first arm 101 has a first end 101A and second arm102 has a second end 102A. In some embodiments, first end 101A andsecond end 102A are connected. In some embodiments, first end 101A andsecond end 102A are not connected, leaving an opening in between themthrough which a port may be inserted and removed from the device (aswill be discussed below).

In some embodiments, first arm 101 and second arm 102 extend from base100. In some embodiments, first and second arms are attached to thedevice independent of the base 100. In these embodiments, base 100 isitself attached to a single base along with separately attached firstarm 101 and second arm 102. In some embodiments, base 100 is designed tobrace the device against a port within an individual. When base 100interfaces with the port, frictional forces prevent device 1 fromsliding past the port. The first arm 101 and the second arm 102 thenprovide additional structures upon which device 1 can interface with thesubcutaneous port. With base 100 substantially preventing forwardmovement of device 1 with respect to the port and the user, first andsecond arms substantially prevent side-to-side movement of device 1. Insome embodiments, additional frictional forces are provided betweendevice 1 and the patient's skin to limit movement of device 1 relativeto the skin, such as through contact between manipulation mechanismplatforms (discussed in greater detail below) and the skin's surface. Insome embodiments, the shapes of base 100, first arm 101, and/or secondarm 102 are substantially crescent-shaped. In other embodiments, theshapes of base 100, first arm 101, and/or second arm 102 are triangular,rectangular, and the like.

In some embodiments, the user engages with device 1 using their hands.In some embodiments, the user engages with device 1 using their fingers.Specific engagement schemes depend on the specific configuration ofdevice 1 and vary based on user preference. FIG. 2 shows exemplaryembodiments of the device designed to be maneuvered by a user's indexand middle finger. FIG. 3 shows an exemplary embodiment of the devicedesigned to be maneuvered by a user's index finger and thumb. One ofskill in the art would understand that various combinations of a user'sfingers may be used to manipulate the devices and could design platformsoptimized for use with those specific finger combinations. Referring toFIG. 5, the user engages with an embodiment of device 1 at a handle viaany suitable manner, such as with their palm or finger tips.

Referring again to FIGS. 2, 3, and 5, these drawings show exemplaryembodiments of the above-identified manipulating mechanism 103. In someembodiments, manipulation mechanism 103 is apart from at least one ofbase 100, first arm 101, and second arm 102. In some embodiments,manipulation mechanism 103 is adjacent to at least one of base 100,first arm 101, and second arm 102. In some embodiments, manipulationmechanism 103 extends from base 100, first arm 101, and second arm 102.In some embodiments, manipulation mechanism 103 is at least one of ahandle, at least one platform, at least one tube, and combinationsthereof. In some embodiments, manipulation mechanism 103 has a covering(as will be discussed in greater detail below).

The purpose of manipulating mechanism 103 is two-fold. Firstly,manipulating mechanism 103 allows a user to position the base 100, firstarm 101, and second arm 102 relative to the port. Secondly, manipulatingmechanism 103 allows this positioning to occur while the user remainsprotected from injection devices that may be around injection site 10.One embodiment wherein manipulating mechanism 103 is shown to be ahandle is shown in FIG. 5. A user grasping one end of the handle (forexample, such as in the manner of a magnifying glass) is able tomaneuver base 100, first arm 101, and second arm 102 at the other end ofthe handle. Once the port has been essentially immobilized by the user'splacement of base 100, first arm 101, and second arm 102 adjacent to theport, the user can continue to hold the port in place relative to device1 from a distance while performing other tasks, such as obtaining therelevant injection device, moving the relevant injection device intoplace to inject the target individual, and physically injecting thetarget individual using the injection device. Throughout those processsteps, the user's hands and other parts of their body are protected fromaccidental self-injection by the distance afforded to them by the handleof device 1, thus limiting the possibility of an accident.

One embodiment wherein manipulating mechanism 103 is a plurality ofplatforms is shown in FIGS. 2 and 3. Referring specifically to FIG. 2,the platforms are attached to the device to provide stable regions fromwhich a user may interact with device 1. In some embodiments, theplatforms are attached to base 100. In some embodiments, the platformsare attached to at least one of first arm 101 and second arm 102. Insome embodiments, interaction by objects with these platforms allows fordevice 1 to be maneuvered with respect to a subcutaneous port and thenheld in place once device 1 is moved into the proper position. Once atleast one of base 100, first arm 101, and second arm 102 are moved intoposition adjacent to a port, the user presses on the platforms, thuspressing the device onto the skin of the individual to receive theinjection. Frictional forces prevent significant movement of the devicerelative to the skin, and the dual platforms provide additional controlto the user to prevent rotation or translation of device 1.

In some embodiments, the platforms have raised sidewalls to helpposition objects, such as a user's fingers, in the proper position uponthe platforms. In some embodiments, the platforms are curved. In someembodiments, the platforms are oriented vertically.

Referring now to FIG. 4, in some embodiments, the platforms include atleast one upper portion 104. In some embodiments, upper portion 104covers the platform and defines a cavity 105 between it and the platformbelow it. In some embodiments, manipulation mechanism 103 is a tube(such as a cylindrical tube, square tube, and the like). In thisembodiment, upper portion 104 acts as a shield to prevent injectiondevices from entering cavity 105. Upper portion 104 also providesincreased surface area for enabling increased control over device 1 by auser (e.g. the covering makes it more difficult for device 1 toaccidentally disengage from a user). In embodiments where device 1 ismanipulated via a user's fingers inserted into these cavities 105, thosefingers are shielded from the environment while the user performs othertasks such as obtaining the relevant injection device, moving therelevant injection device into place to inject the target individual,and physically injecting the target individual using the injectiondevice. While conventional methods of injection into a subcutaneous portrequired the fingers of the person injecting to be close to theinjection site, and thus vulnerable to errant needle sticks, upperportion 104 according to some embodiments of the instant disclosureprovides protection against these sticks, as upper portion 104 wouldabsorb the impact of the needle before it could make contact with theuser's fingers.

Manipulating mechanisms 103 as described herein may be combined ormultiplied as a matter of design choice that is well within theabilities of one having skill in the art.

Referring again to FIG. 4, in some embodiments, at least one of base100, first arm 101, and second arm 102 further comprise a stabilizingmechanism 106. In some embodiments, stabilizing mechanism 106 is asidewall. In some embodiments, stabilizing mechanism 106 is angled. Inthese embodiments, at least one of base 100, first arm 101, and secondarm 102 have a sidewall that while normally vertical (i.e. substantiallyperpendicular to the skin of the individual requiring an injection) isinstead angled to facilitate acceptance of the port into base 100, firstarm 101, and/or second arm 102.

Referring now to FIG. 6, the embodiment shown is consistent with theembodiments described above, but further including an adjustable region107 in base 100. In some embodiments, at least one of base 100, firstarm 101, and second arm 102 are adjustable. In some embodiments, theadjustment at least one of base 100, first arm 101, and second arm 102performed via a hinge, a ratchet, a piston, a track, and the like. Byallowing the stabilizing base, the first arm, and/or the second arm tobe adjustable, device 1 is more compatible with different sized portsand allows a user to have greater control over the device while in use.In the embodiment shown in FIG. 6, adjustable region 107 is a hingeplaced in base 100, allowing flex at three places. With the user'sfingers inserted into manipulating mechanism 103 (platforms in thiscase), the user can spread his or her fingers wide to open the first andsecond arms to the greatest possible extent (region 107 lies flat) whilemaneuvering device 1 towards a port. Once device 1 has been positioned,the user moves their fingers closer together, bending the hinge, andbringing first arm 101 and second arm 102 closer together. The result isa pincer movement that allows the user to more easily secure the portwithin device 1. The adjustability of device 1 described in thisembodiment means that the above-identified method may be performed onports of different sizes.

FIGS. 7 and 8 are directed to a method of stabilizing a subcutaneousport consistent with some embodiments of the present disclosure. In someembodiments, the method comprises the step of a user engaging 700 adevice (such as device 1 described above) via at least one manipulationmechanism. The device is then contacted 710 with the patient and/or theport proximate the port and stabilized 720 there, thus limiting movementof the device relative to the port and the patient. The device contactis maintained 730 proximate the port until a needle is inserted into theport. In some embodiments, contact is maintained 830 via a stabilizingmechanism between the port and at least one of the base, firm arm, andsecond arm. As used herein, “contact” between a component of the deviceand the subcutaneous port includes “indirect” contact, i.e. where layerssuch as bandages, protective films, or a patient's own skin, fat, orother tissue, and combinations thereof and the like are disposed betweenthe device and the port.

In one embodiment showing an exemplary method including a deviceconsistent with the instant disclosure, a user identifies a subcutaneousport in an individual that is to receive an injection. The user thenmaneuvers the device towards the port using the manipulation mechanism.The device is then pressed onto the skin of the individual and heldadjacent to the port using at least one of the stabilizing base, thefirst arm, and the second arm. In some embodiments, the device is heldadjacent to the port with the port substantially encircled by thestabilizing base, the first arm, and the second arm. One furtheradvantage of this embodiment is that the device itself highlights theinjection site for the user, creating a clearly defined andsubstantially immobile target at which the user can aim the injectiondevice. Contact between at least one of the stabilizing base, the firstarm, and the second arm holds the port substantially immobile withrespect to the subcutaneous port. Thus immobilized, the user injects theindividual through the port. The user then removes the injection deviceand the device itself.

In some embodiments, while the manipulation mechanism may be directly orindirectly connected to the one or more of the stabilizing base, firstarm, and second arm, the manipulation mechanism is configured such thatthe user interacts with the manipulation mechanism at a location remoteor apart from the stabilizing base, first art, or second arm. Configuredthusly, the user manipulates the base, first arm, or second arm withoutthe need to interact directly with any of those features using theirhands or other part of their body.

The method steps discussed above may be performed in any suitable order.

In some embodiments, the device is fashioned from plastic, metal, wood,or any other suitable material and combinations thereof. In someembodiments, the device is provided as a kit having different sizeddevices to accommodate differently sized individuals and ports.

Although the invention has been described and illustrated with respectto exemplary embodiments thereof, it should be understood by thoseskilled in the art that the foregoing and various other changes,omissions and additions may be made therein and thereto, without partingfrom the spirit and scope of the present invention.

What is claimed is:
 1. A device for stabilizing a subcutaneous port,comprising: a first arm; a second arm opposing the first arm; a firstmanipulation mechanism laterally adjacent the first arm, the firstmanipulation mechanism including a first shield including an outersurface extending from a first end integrated with the firstmanipulation mechanism to a second end integrated with the firstmanipulation mechanism; and a second manipulation mechanism laterallyadjacent the second arm, the second manipulation mechanism including asecond shield including an outer surface extending from a third endintegrated with the second manipulation mechanism to a fourth endintegrated with the second manipulation mechanism.
 2. The deviceaccording to claim 1, wherein the first manipulation mechanism andsecond manipulation mechanism are apart from the first arm and thesecond arm.
 3. The device according to claim 1, wherein the firstmanipulation mechanism and second manipulation mechanism extend from atleast one of the first arm and the second arm.
 4. The device accordingto claim 1, wherein at least one of the first arm and the second armfurther comprise a stabilizing mechanism.
 5. The device according toclaim 4, wherein the stabilizing mechanism is a sidewall.
 6. The deviceaccording to claim 5, wherein the sidewall is provided at an angle. 7.The device according to claim 4, wherein at least one of the first arm,the second arm, the first manipulation mechanism, the secondmanipulation mechanism, and the stabilizing mechanism is adjustable. 8.The device according to claim 4, wherein at least one of the first arm,the second arm, the first manipulation mechanism, the secondmanipulation mechanism, and the stabilizing mechanism is flexible. 9.The device according to claim 1, wherein the first arm has a first armend and the second arm has a second arm end, wherein an openingseparates the first arm end from the second arm end.
 10. The deviceaccording to claim 4, wherein at least one of the first arm, the secondarm, the first manipulation mechanism, the second manipulationmechanism, and the stabilizing mechanism is configured to interface witha patient's skin and stabilize the device against the patient's skin.11. The device according to claim 4, wherein at least one of the firstarm, the second arm, and the stabilizing mechanism is curved.
 12. Adevice for stabilizing a subcutaneous port, comprising: a first arm, thefirst arm having a first arm end; a second arm opposing the first arm,the second arm having a second arm end; a first manipulation mechanismlaterally adjacent the first arm, the first manipulation mechanismincluding a first shield including an outer surface extending from afirst end integrated with the first manipulation mechanism to a secondend integrated with the first manipulation mechanism; a secondmanipulation mechanism laterally adjacent the second arm, the secondmanipulation mechanism including a second shield including an outersurface extending from a third end integrated with the secondmanipulation mechanism to a fourth end integrated with the secondmanipulation mechanism; and an adjustable region including a hingedisposed between the first manipulation mechanism and the secondmanipulation mechanism; wherein at least one of the first arm and thesecond arm comprise a stabilizing sidewall configured to maintaincontact between the subcutaneous port and the device.